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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K921955
Device Name QUIK FLOW
Applicant
California Medical Equipment, Inc.
P.O. Box 18254
Irvine,  CA  92713
Applicant Contact MEHMET BICAKCI
Correspondent
California Medical Equipment, Inc.
P.O. Box 18254
Irvine,  CA  92713
Correspondent Contact MEHMET BICAKCI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/27/1992
Decision Date 01/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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